Labeling Operations Specialist
2 months ago
Job Summary
The successful candidate will be responsible for coordinating the implementation of artwork and labeling for Pfizer's products. This role will involve working closely with cross-functional teams to ensure that all regulatory requirements are met and that artwork is delivered on time.
Key Responsibilities
- Initiate and build Pfizer Artwork Requests (PARs) in collaboration with local markets, ensuring all required information, specifications, and documentation are available for production.
- Negotiate Artwork Change Control logistics across multiple departments and markets to ensure regulatory timelines are met and product supply is not interrupted.
- Track artwork, Key Performance Indicators (KPIs), and quality metrics for assigned projects and regional or departmental deliverables.
- Research root cause assessments for internal artwork Quality Investigations or meetings, identify opportunities for continuous improvements, and prepare formal recommendations to artwork management leadership.
- Retrieve documents and/or generate reports in response to queries from Regulatory Agencies or Assistant General Counsel.
- Represent Artwork and Launch Implementation Management (ALIM) on cross-functional projects or lead ALIM continuous improvement teams, coordinating activities of other ALIM staff or contractors.
- Liaise with markets and stakeholders to gather necessary information to initiate and build PARs, enabling plant production of labeling artwork with minimal rework and meeting implementation requirements.
- Create Editor's Copy (EC) for select markets depending on language(s) involved and specific custom services negotiated with markets.
- Liaise with Global Regulatory Operations, Global Label Management/International Labelling Group functions, GRS PCOs, and PGS AWCs to coordinate unique factors, document agreement on Artwork timelines, and escalate issues/concerns within ALIM functional line and/or relevant leadership.
- Perform artwork system Market Coordinator role, according to agreed timelines and established procedures, by evaluating content of labeling updates, raising potential issues with GRS, PGS, or local markets, and initiating PARs in collaboration with assigned market(s).
- Use Biopharmaceutical Packaging & Artwork knowledge, in combination with Trade Dress Style Guides, Country Specific Requirements, and/or other guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs.
- Send PARs to all relevant PGS sites, monitor and follow up on any aging PARs, and initiate, manage, and track any necessary rework.
- Identify appropriate Market Approvers for Packaging Artwork, electronically route for approval using artwork lifecycle management system, and monitor progress and follow up as needed.
- Track and communicate final approved labeling to relevant departments and stakeholders following final market review and signoff.
- Upload any locally reconditioned or repackaged Artworks into artwork management system to assure correct Artworks are available for next revision cycle.
- Lead teams in development and revisions of relevant SOPs for functional area.
- Work with minimal direct supervision, provide training and support to other team members or external vendors as required, and oversee work of other internal temporary personnel or external vendor staff as needed.
Work Environment
The successful candidate will be based in Pfizer's offices in the UK or Romania, working in a collaborative and dynamic environment with a focus on delivering high-quality results.
About Pfizer
Pfizer is a patient-centric company guided by its four values: courage, joy, equity, and excellence. Our breakthrough culture enables us to transform millions of lives through our dedication to innovation and excellence.
Equal Employment Opportunity
Pfizer is committed to celebrating diversity and inclusion in all its forms, allowing us to build a successful business that reflects the patients and communities we serve.
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